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In 505(b)(2) development, programs are often derailed when sponsors lack experience with the specific processes and requirements of the approval pathway. These mistakes can lead to unnecessary trials being conducted, clinical holds, or the needless discontinuation of development. Download our guide to learn how to rectify past missteps and avoid future ones in 505(b)(2) product development. Premier Consulting. Built for Biotech℠.
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Today's Big NewsJan 19, 2023 |
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Tuesday, January 24, 2023 | 11am ET / 8am PT Your CRO is a finalist in a project bid and clinical supplies are one of the aspects that you will manage on behalf of the client via a partner. Register now.
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| By James Waldron Just 10 days after announcing plans to let go of its iNK programs as part of a major portfolio and workforce restructuring, Editas Medicine has found a buyer for the cell technologies in the form of Shoreline Biosciences. |
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By Nick Paul Taylor Fresh from its $325 million opt-in, Jazz Pharmaceuticals has posted phase 2 data on its HER2-targeted bispecific antibody zanidatamab. The Zymeworks-partnered prospect kept 84% of people with metastatic gastroesophageal cancer alive for at least 18 months when given in combination with chemotherapy. |
By Gabrielle Masson If there's been a theme to 2023 so far, it's mid-size companies taking the plunge and making an offer on their biotech peers. The latest example is Sun Pharmaceutical, which has put down $576 million to acquire Concert Pharmaceuticals and its JAK inhibitor that could give Eli Lilly's approved alopecia treatment a run for its money. |
Sponsored by Evidation Health Traditional real-world data isn’t truly from the real world – it’s from the clinical world, and it’s missing a big part of neuro patients’ stories. |
By James Waldron If we’re looking for good omens for biotech in 2023, then a planned $100 million IPO seems as good a sign as any. That’s how much Mineralys Therapeutics is aiming to bring if it goes public as planned. |
By Nick Paul Taylor Iain Ross has made an immediate mark on ReNeuron, overseeing a restructuring to reduce the biotech’s head count by 40% within weeks of taking the reins. The cuts extend the stem cell player’s cash runway out to 2024, partly easing the pressures that built up as it struggled to raise money last year. |
By Gabrielle Masson Wilbur Ross' SPAC and Alzheimer’s focused-Aprinoia Therapeutics have inked one of the first biotech blank check deals of the new year, reigniting hope in the chilly SPAC waters. |
By Gabrielle Masson Gilead is expanding with a new research center that's plotted in headquarters Foster City, California, as it races to develop 10 new transformative therapies. |
By Joseph Keenan PsychoGenics has signed on with Italy's Iama Therapeutics to run a preclinical study as part of an effort to identify and develop drug candidates to treat Dravet syndrome. |
By Angus Liu Nearly three years after snatching the first-in-class FDA approval in metastatic liver cancer, a combination of Roche’s Tecentriq and Avastin has come back with an industry-first win in early-stage disease. And the PD-L1 inhibitor is looking at a busy year with potentially four adjuvant readouts on deck. |
By Dave Muoio An 11-hospital sample of about 2,800 admissions published in The New England Journal of Medicine found 978 adverse events, about a third of which were judged to be serious or worse. |
By Andrea Park Surmodics looks to pave a new path forward after the FDA sent a device submission back for revision yet again. |
By Eric Sagonowsky Just about a week after saying its cash could fund operations until early next year, bluebird bio has raised $113 million by selling new shares of its stock. The money should fund operations through the fourth quarter of 2024. |
By Dave Muoio In an address to Cleveland Clinic employees, CEO and President Tom Mihaljevic, M.D., said the organization plans to cut back on spending and administrative hiring. |
Fierce podcastsDon't miss an episode |
| This week on “The Top Line,” we discuss the biotech industry’s rotten tomatoes. Plus, we cover the drug approvals of last year, a congressional report on Biogen's "inappropriate" communications with the FDA and other top headlines from this week. |
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Tuesday, January 31, 2023 | 11:00am ET This Webinar will highlight the comprehensive set of tools that Aldevron developed to support advancing mRNA projects to clinic. In addition, an overview of the technology transfer program, analytical and process characterization, release, and stability will be discussed with an insight into Aldevron’s integrated CMC capabilities ranging from transcript design and product profile definition through encapsulation and fill/finish. Register now.
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| WhitepaperRCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease. Sponsored by: Unlearn AI |
| Whitepaper What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
| WhitepaperThis paper explores how Medical Affairs is adapting medical communications to meet the demands of a new environment (part 5 in a series). Sponsored by: Blue Matter, strategic consultants in the life sciences |
| On-Demand Webinar See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
| Executive Summary Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more. Sponsored by: Catalent |
| WhitepaperHow can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
| Whitepaper Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
| WhitepaperExplore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
| Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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